CDSCO Regulations for Dialysis Machine Manufacturing in India

Written by Sudhriti M

14 May 2024

In the recent past, there has been an increasing prevalence of chronic and acute kidney failure incidences in India. Dialysis treatment can help improve the quality of life of these patients. However, owing to the paucity of low-cost dialysis machines in India, most patients cannot access this treatment. Entities planning to enter the medical device manufacturing business can focus on dialysis machine manufacturing. Owing to the high demand for low-cost and high-quality dialysis equipment, manufacturers can tap into the dialysis machine manufacturing industry. Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for all medical devices manufactured, sold, and distributed in India. CDSCO regulatory approval is required to manufacture dialysis machine in India. In this blog, we will focus on why dialysis machine manufacturing in India has promising potential for medical device businesses. Additionally, we will understand the CDSCO regulations for dialysis machine manufacturing.

Dialysis and dialysis machines

In case the kidney fails to function properly, waste products and excessive fluid accumulate in the body, which is detrimental. Kidney failure may be caused by various factors, such as high blood pressure, diabetes, and other causes. Dialysis, which works on the principle of diffusion and ultrafiltration, assists the kidney with its function of waste and excess fluid elimination.

Types of dialysis usually performed:

  • Hemodialysis
  • Peritoneal dialysis

The dialysis machine filters the blood to remove the excess fluid and waste accumulated in the body. The dialysis machine takes on the role of the kidneys to cleanse the blood. It is basically a medical device used to treat acute or chronic kidney failure.

In India, there has been a drastic increase in the number of individuals with diabetes and hypertension. Both these are driving factors for the rise in prevalence of end-stage kidney disease, which is associated with high mortality. Dialysis treatment can improve the quality of life of these patients.

Urgent need for dialysis machine manufacturing in India

Approximately 200,000 individuals in India develop end-stage kidney disease every year. Most of them are unable to access or even afford dialysis treatment for end-stage kidney disease. Dearth of dialysis infrastructure, machine, and accessibility negatively impacts survival outcome of these patients. The major hurdle in end-stage kidney disease treatment is the lack of accessibility and affordability of dialysis treatment. To overcome this hurdle, the Indian government has introduced the National Dialysis Program. This will fuel the demand for dialysis machines and improved dialysis infrastructure. Thus, this will drive dialysis machine manufacturing in India.

A recent study published in Kidney International Reports highlighted the need for dialysis machine manufacturing in India. The study highlighted that most dialysis machines used in India are imported. This shoots up the cost of dialysis treatment, thus making it unaffordable to most patients. Additionally, lack of maintenance of the machines and unavailability of spare parts for imported devices adversely impacts the treatment quality. High quality, innovative, and cost-effective dialysis machines manufactured in India will improve affordability and accessibility to dialysis treatment. This in turn will improve the quality of lives of patients with end-stage kidney disease.

Dearth of dialysis machines and infrastructure, high-cost of imported devices, and the National Dialysis Program are propelling dialysis machine demand. Inability to afford dialysis treatment as well as a lack of equipment are major barriers to acute/chronic renal failure care. Low cost and high-quality dialysis machines manufactured in India will boost and improve the dialysis care delivered in India. Hence, manufacturing dialysis machine in India will be a potential business for medical device manufacturers.

CDSCO regulations for dialysis machine manufacturing

Dialysis machine manufacturing in India is regulated by the CDSCO. As per CDSCO guidelines, dialysis machines and equipment marketed in India need to be registered with the CDSCO. CDSCO regulations for dialysis machines monitor and control their safety, quality, and efficacy. Given the impact and demand for the equipment in the Indian market, regulatory guidelines are needed to ensure patient safety. CDSCO regulations for dialysis machine manufacturing ensure substandard and inferior quality machines do not enter the Indian market. Inferior quality devices can lead to inaccurate treatment that can be detrimental for this critical group of patients. Hence, strict CDSCO regulations for dialysis machine manufacturing ensure high quality dialysis treatment is provided to the patients. This in turn ensures that the quality and standard of the Indian healthcare sector is maintained.

CDSCO class for dialysis machines

For the ease of CDSCO registration, the regulatory body has categorised medical devices into four classes. In the ascending order of risk level, Class A, B, C, and D are the four CDSCO medical device classes. As defined by CDSCO, dialysis machines are used to treat acute or chronic kidney failure. It filters blood to remove the excess water and waste products accumulated in the body. Depending on the risk level and intended use, CDSCO has classified the dialysis machines as Class C.

Documents required and application process per CDSCO regulations for dialysis machines

CDSCO regulations for dialysis machines have specified the required documents and application process for these medical devices.

  • Manufacturing license: Entities seeking to obtain a license for manufacturing dialysis machines in India need to apply using the Form MD-7. The dialysis machine manufacturing company has to apply online and pay the necessary processing fee. Medical device regulatory officers will inspect the production facility within 60 days from the date of application. The regulatory body will relay the approval via Form MD-9. This will permit the manufacturing company to manufacture, sell, and distribute dialysis machines in India.
  • Loan license: A loan license can be used to manufacture medical devices when the manufacturer does not own a manufacturing facility. Manufacturers seeking to obtain a loan license for manufacturing dialysis machines in India need to apply using the Form MD-8.  The medical device manufacturer has to apply online and pay the necessary processing fee. Medical device regulatory officers will inspect the production facility within 60 days from the date of application. The regulatory body will relay the approval via Form MD-10. This will permit the manufacturer to manufacture, sell, and distribute dialysis machines in India with a loan license.

For registration per CDSCO regulations for dialysis machines, necessary supporting documents are required. Separate sets of supporting documents are required depending on the application form. CDSCO has provided a detailed checklist of documents that should accompany each application form. The checklist can be found here.

License approving authority

Manufactures seeking to obtain a license for dialysis machine manufacturing in India need to apply to the Central Licensing Authority (CLA). The CLA grants licenses for all Class C and D medical devices manufactured, distributed, and sold in India.

Do you want to register your dialysis machine in India?

Do you want to register your dialysis machine per CDSCO regulations for dialysis machine manufacturing in India? Well, look no beyond. The Pharmadocx Consultants team is right at our service. Registering medical devices in India is our forte. Let us help you sort out your dialysis machine manufacturing application. Our expertise in this field will ensure your registration process is free from any hiccups. Drop us an email at [email protected] or call/Whatsapp us at 9996859227 and we will help you register your dialysis machine in India. CDSCO medical device registration is the first step to establishing a medical device manufacturing business in India.

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